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Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
NCT06044610 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise study in moderately active participants in both dehydrated and euhydrated states (EXERCISE). TOI data will be collected alongside standard reference measures of hydration status. This is an exploratory pilot proof of concept study with each subject serving as their own control.
Conditions Studied
Interventions
- OTHER GENPOP Passive dehydration (75% reduction in fluid intake
- OTHER GENPOP Ad lib fluid intake
- OTHER EXERCISE without fluid replacement
- OTHER EXERCISE with fluid replacement
Study Locations (2)
New York
- PepsiCo R&D, Gatorade Sports Science Institute — Valhalla
Texas
- PepsiCo R&D, Gatorade Sports Science Institute — Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2023-11-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06044610
The ClinicalTrials.gov registry entry for NCT06044610 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PepsiCo Global R&D, which has 76 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Dehydration appearing as the primary indexed condition, and to 4 interventions — of which GENPOP Passive dehydration (75% reduction in fluid intake is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06044610 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06044610 about?
NCT06044610 is a clinical study titled "Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development". The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydrat...
What is the current status of trial NCT06044610?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2023-05-08. Estimated completion is 2023-11-15.
What conditions does trial NCT06044610 study?
This clinical trial studies the following conditions: Dehydration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06044610?
The interventions under investigation include: GENPOP Passive dehydration (75% reduction in fluid intake (OTHER), GENPOP Ad lib fluid intake (OTHER), EXERCISE without fluid replacement (OTHER), EXERCISE with fluid replacement (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06044610?
This trial is sponsored by PepsiCo Global R&D, which has 76 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06044610 being conducted?
This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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